China-based Venus Medtech (Hangzhou) Inc. (HKG: 2500) has announced that all patients have been successfully enrolled in a confirmatory study in China for its Liwen RF ablation system, designed for the treatment of hypertrophic cardiomyopathy (HCM). This marks a significant step forward in the clinical development of this innovative device.
About the Liwen RF Ablation System
The Liwen RF ablation system, developed in-house by Hangzhou Nuocheng Medical Technology Co., Ltd—a wholly-owned subsidiary of Venus Medtech—offers several technical advantages for the treatment of HCM. These include reduced trauma, precise localization, no target vessel restriction, significant reduction of septal thickness, and reduced risks of conduction system damage and other complications. The system provides a safe, efficient, precise, and less invasive therapy for HCM, representing a significant advancement in the field.
Clinical Results and Regulatory Milestones
In August 2022, the Liwen RF ablation system qualified for the Special Approval Procedures of Innovative Medical Devices promulgated by the National Medical Products Administration (NMPA). Exploratory clinical results have shown that, compared to the traditional gold standard surgical procedure, the Liwen RF ablation system achieved an 88% success rate, with no death cases reported one year post-operation. Patients also experienced significant improvements in clinical performance, cardiac function, and quality of life. The system was found to be significantly better than septal myectomy surgery and alcohol septal ablation, providing robust evidence of its safety, efficacy, and superior performance.
Future Prospects
The completion of patient enrollment in the confirmatory study is a crucial milestone for the Liwen RF ablation system. As the clinical trial progresses, the data collected will further validate the system’s potential to transform the treatment landscape for HCM. With its innovative approach and strong clinical results, the Liwen RF ablation system is poised to become a leading treatment option for patients suffering from this condition.-Fineline Info & Tech
